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Outlook Therapeutics Meets with FDA to Address CRL for Ophthalmic Bevacizumab Formulation

Nov 27, 2023

Outlook Therapeutics announced that it had a ‘Type A’ meeting with the FDA in October 2023 to discuss the Complete Response Letter (CRL) it received in August 2023 regarding its Biologics License Application (BLA) for ONS-5010, an ophthalmic formulation of bevacizumab, marketed by Genentech as Avastin®, to treat wet AMD.  On 29 September 2023 Outlook Therapeutics requested a Type A meeting with the FDA (an immediately necessary meeting for a drug development program to proceed).  The FDA confirmed in the Type A meeting that Outlook can conduct a non-inferiority study evaluating ONS-5010 versus ranibizumab in a 3-month study of treatment naïve patients with a primary endpoint at 2 months.

In the CRL dated 30 August 2023, the FDA acknowledged the Outlook NORSE TWO pivotal trial met their safety and efficacy endpoints, but suggested the BLA could not be approved due to several chemistry, manufacturing and control issues, as well as open observations from pre-approval manufacturing inspections and a lack of substantial evidence.